Manager, Quality Systems
Core
Leads enterprise Quality Management Systems (QMS) and end-to-end training functions for FDA-registered 503A/503B pharmaceutical manufacturing.
Role type
Manager, Quality Systems (cGMP)
Builds
QMS infrastructure, training programs, and compliance frameworks for personalized medicine and pharmaceutical manufacturing.
Domain
Healthcare / Pharmaceutical Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
QMS design and implementation, cGMP/GMP regulatory expertise, CAPA management, audit leadership, risk management frameworks, training program strategy, cross-functional alignment, validation oversight, change control, team leadership, AI tool integration
Preferred skills
AI-driven signal detection, predictive analytics, digital controls implementation, inspection readiness strategy
Technologies
LMS, AI monitoring tools, predictive analytics platforms, digital workflow automation
Responsibilities
Own design and evolution of QMS and cGMP training systems; drive standardization of quality processes (CAPA, deviations, change control); establish governance frameworks and metrics; lead inspection readiness and risk mitigation; oversee internal/external audits; partner with manufacturing/engineering to embed quality; build and develop high-performing quality teams; design comprehensive GMP training programs.
Seniority
Manager, strategic leadership with rigorous execution
